LC&FIRP: Does a Technology Enabled Multi-disciplinary Team-based Care Model for the Management of Long COVID and Other Fatiguing Illnesses Improve Clinical Care of Patients and Represent a Sustainable Approach Within a Federally Qualified Health Center?

Sponsor
Family Health Centers of San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT05167227
Collaborator
(none)
20
1
2
32
0.6

Study Details

Study Description

Brief Summary

The primary objective of the present research is to determine the effectiveness of Family Health Center of San Diego's Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) on clinician- and patient-level outcomes. LC&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with PASC, ME/CFS, and OPIFI. Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings.

Condition or Disease Intervention/Treatment Phase
  • Other: Extension for Community Healthcare Outcomes
N/A

Detailed Description

The primary objective of the present research is to determine the effectiveness of FHCSD's Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) on clinician- and patient-level outcomes. LC&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with PASC, ME/CFS, and OPIFI. Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings. This study will provide much needed high-quality evidence on the effectiveness of a technology enabled multi-disciplinary team-based care model for the management of PASC, ME/CFS, and OPIFI within a community clinic setting, while simultaneously providing evidence regarding the feasibility, acceptability, and sustainability of the approach. Given that LC&FIRP includes a teleECHO program that is case-based, interactive, and occurs in real-time, it has a set of distinct advantages to the traditional practice of sequential in-person specialty referrals to address complex patient cases. The investigators hypothesize that clinician exposure to weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to clinician exposure to monthly interactive webinars and quarterly short courses alone.

The investigators will evaluate LC&FIRP using an effectiveness-implementation hybrid type 2 design. Specifically, the investigators will conduct a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial. The target for weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses are licensed health care professionals. Therefore, the present research will include professional clusters that will consist of primary care physicians, physician assistants, and nurse practitioners at FHCSD caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with PASC, ME/CFS, and/or OPIFI.

20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). All clinicians will have the option to receive continuing medical education credit for the educational sessions they engage in. Throughout participation, the investigators expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with PASC, ME/CFS, or OPIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians. Outcomes will be measured at 3-, 6-, 9-,12-, 18-, 24-, 30-, and 33-months post-baseline for clinicians and for patients at 3-, 6-, 9-, and 12-months post assignment to a participating clinician.

Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with PASC, ME/CFS, and/or OPIFI, and 4) being willing and able to actively participate in LC&FIRP. There are no exclusion criteria. FHCSD medical leadership has verbally extended an invitation to the approximately 200 eligible clinicians at FHCSD to participate in LC&FIRP (a follow-up email will also be sent). Those who are interested will provide written informed consent, complete a baseline survey, and will be randomized to one of the two study arms. An electronic randomization list will be generated using the latest version of the statistical software platform R (version 3.3.2, http://www.r-project.org). The list will be securely integrated into the cloud-based Research Electronic Data Capture (REDCap) tool. Allocation will be concealed from all investigators and staff until the study group is assigned. Only the study manager and research assistants involved in the delivery of the intervention components will subsequently be made aware of allocation. It is not possible to mask participating clinicians, however, patients of participating clinicians will not have knowledge of their clinicians potential participation in weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses. All staff that are involved in the collection of data and investigators that conduct analyses will remain blinded to allocation throughout the study.

Clinician participation in this study is voluntary. Participating clinicians may decide not to participate or may leave the study at any time. This decision will not result in any penalty or loss of benefits to which they are entitled. Information that has already been collected may still be used, but no new information will be collected. The withdrawal reason and the withdrawal date will be documented.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). Throughout participation, we expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with PASC, ME/CFS, or OPIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians.20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). Throughout participation, we expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with PASC, ME/CFS, or OPIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Allocation will be concealed from all investigators and staff until the study group is assigned. Only the study manager and research assistants involved in the delivery of the intervention components will subsequently be made aware of allocation. It is not possible to mask participating clinicians, however, patients of participating clinicians will not have knowledge of their clinicians potential participation in weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses. All staff that are involved in the collection of data and investigators that conduct analyses will remain blinded to allocation throughout the study.
Primary Purpose:
Treatment
Official Title:
The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

The Control arm participates in monthly interactive webinars and quarterly short courses. Monthly interactive webinars will offer brief didactic presentations by SMEs, examples of models of care, and a facilitated Q&A. These webinars will be convened to rapidly disseminate findings and emerging best practices to a large-scale, national audience. Quarterly short courses will be developed to summarize key findings from past weekly teleECHO sessions. These quarterly short courses will be formatted as a learning module with the use of presentation slides and videos online that are accessible asynchronously.

Experimental: Intervention

The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses.

Other: Extension for Community Healthcare Outcomes
ECHO is a technology enabled multi-disciplinary team-based care model centered on case-consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO) to support management of complex cases associated with PASC, ME/CFS, and OPIFI.
Other Names:
  • ECHO
  • Outcome Measures

    Primary Outcome Measures

    1. Patient-Reported Outcomes Measurement Information System (PROMIS)-29 [During 12 months of follow-up]

      Patient baseline and quarterly surveys

    Secondary Outcome Measures

    1. Patient symptom checklist with associated severity for those present [During 12 months of follow-up]

      Patient baseline and quarterly surveys, None, Mild, Moderate, Severe

    2. If symptom is present, has patient experienced this in the past month [During 12 months of follow-up]

      Patient baseline and quarterly surveys, Yes/No

    3. If symptom is present, how long has patient experienced this symptom [During 12 months of follow-up]

      Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer

    4. If symptom is present, did patient have this symptom before you tested positive for COVID-19? [During 12 months of follow-up]

      Patient baseline and quarterly surveys, Yes/No

    5. If symptom is present, during the past month how often have you had this symptom? [During 12 months of follow-up]

      Patient baseline and quarterly surveys with use of Likert scale

    6. If symptom is present during the past month, how bad was this symptom? [During 12 months of follow-up]

      Patient baseline and quarterly surveys with use of Likert scale

    7. For symptoms present, do any of them get worse for at least 24 hours after engaging in activities (physical or mental) that patient was used to doing with no problems? [During 12 months of follow-up]

      Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know

    8. If fatigue, tiredness, or exhaustion is present, doesn't patient describe it as feeling it come on all of a sudden, or slowly over time [During 12 months of follow-up]

      Patient baseline and quarterly surveys with All of sudden, Slowly over time, Not applicable, Don't know

    9. If fatigue present, what month and year did the fatiguing illness begin? [During 12 months of follow-up]

      Patient baseline and quarterly surveys, estimated month and year

    10. When fatigued, does rest make patient's fatigue better? [During 12 months of follow-up]

      Patient baseline and quarterly surveys, Yes a lot, Yes a little, No not very much, Not applicable, Don't know

    11. When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities? [During 12 months of follow-up]

      Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know

    12. Patient's medical history check-list [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Yes, No, Unsure

    13. Patient's dietary restrictions [Through study referral period, an average of 12 weeks]

      Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other

    14. Patient's food allergies or other food intolerances [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Yes/No

    15. Has patient's employment been impacted due to contracting COVID-19? [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Yes, No

    16. Patient's frequency to complete 150-minutes per week of moderate-intensity physical activity (like a brisk walk, slow biking, gardening, or ballroom dancing) prior to contracting COVID-19 [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know

    17. Patient's frequency to complete 150-minutes per week of vigorous-intensity physical activity (like running, swimming laps, competitive sports, or fast bicycling) prior to contracting COVID-19 [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know

    18. Did patient receive a COVID-19 PCR (nasal swab) test [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Yes/No

    19. Did patient receive a COVID-19 antibody test [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Yes/No

    20. Patient symptom onset [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Date

    21. Patient reported medications used for COVID-19 symptoms [Through study referral period, an average of 12 weeks]

      Patient baseline survey, free text

    22. Patient reported prescribed supplementary oxygen support [Through study referral period, an average of 12 weeks]

      Patient baseline survey, Yes/No

    23. Patient reported admittance to hospital due to COVID-19 [During 12 months of follow-up]

      Patient baseline and quarterly surveys, Yes/No

    24. Do any of the following activities exacerbate patients symptoms: Physical exertion, Diet Changes, Big Meal, Dehydration, Weather changes (hot and humid), Tight clothing, Stress or anxiety, Pre Menstrual period, Menstrual period, Alcohol consumption [During 12 months of follow-up]

      Patient baseline and quarterly surveys, Yes/No

    25. Does patient feel fully recovered from COVID-19 [During 9 months of follow-up]

      Patient quarterly surveys, Yes/No

    26. Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing) [During 9 months of follow-up]

      Patient quarterly surveys, free text

    27. Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling) [During 9 months of follow-up]

      Patient quarterly surveys, free text

    28. Patient Health Questionnaire (PHQ)-2 [During 12 months of follow-up]

      Patient baseline and quarterly surveys

    29. Patient Health Questionnaire (PHQ)-9 (if applicable) [During 12 months of follow-up]

      Patient baseline and quarterly surveys

    30. PROMIS Dyspnea Functional Limitations and Severity Short Forms [During 12 months of follow-up]

      Patient baseline and quarterly surveys

    31. PROMIS Applied Cognition Abilities and General Concerns Short Forms [During 12 months of follow-up]

      Patient baseline and quarterly surveys

    32. Generalized Anxiety Disorder (GAD)-7 [During 12 months of follow-up]

      Patient baseline and quarterly surveys

    33. 2-minute step test [During 12 months of follow-up]

      Physical Therapy assessment with patient

    34. 30 sec sit to stand test [During 12 months of follow-up]

      Physical Therapy assessment with patient

    35. Grip strength [During 12 months of follow-up]

      Physical Therapy assessment with patient

    36. Functional Gait Assessment [During 12 months of follow-up]

      Physical Therapy assessment with patient

    37. Balance tasks [During 12 months of follow-up]

      Physical Therapy assessment with patient

    38. Post-exertional malaise follow-up [Per Physical Therapy encounter after PT assessment]

      Follow-up Physical Therapy appointment with patient, Not at all, A little bit, Somewhat, Quite a bit, Very much

    Other Outcome Measures

    1. Knowledge improvement of appropriate PASC diagnosis as a result of participation in randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement

    2. Knowledge improvement of effective PASC care and treatment as a result of participation in randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement

    3. Knowledge improvement of approaches for complex cases of PASC as a result of participation in randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement

    4. Self-efficacy in abilities related to identify tools and methods for PASC care [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    5. Self-efficacy in abilities to diagnose patients with PASC [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    6. Self-efficacy in abilities to screen for co-morbidities of PASC [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    7. Self-efficacy in abilities to generate a patient-specific treatment plan for patients with PASC [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    8. Self-efficacy in abilities related to to implement a patient-specific treatment plan for patients with PASC [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    9. Self-efficacy in abilities to select appropriate special or diagnostic tests for PASC patients [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    10. Self-efficacy in abilities to interpret special or diagnostic test results for my PASC patients [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    11. Self-efficacy in abilities to provide appropriate patient education about their PASC condition [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    12. Self-efficacy in abilities to educate clinic staff about PASC care [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    13. Self-efficacy in abilities to address PASC patients using a multidisciplinary approach [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    14. Self-efficacy in abilities to assess and manage concerns that PASC patients face [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    15. Self-efficacy in abilities to assess severity of disease in patients with PASC [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    16. Self-efficacy in abilities to deal with complex cases of PASC [During 33 months of follow-up]

      Clinician baseline and quarterly follow-up survey with use of Likert scale agreement

    17. Utility of an encountered case presented during randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey Yes/No

    18. Overall satisfaction with randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement

    19. Satisfaction to recommend to colleague randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale likelihood

    20. Satisfaction to participate in future randomized arm (teleECHO or monthly webinar) again [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale likelihood

    21. Changes to practice in helping colleague with information learned from randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey Yes/No

    22. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to understand further monitoring and follow-up plan [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement

    23. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to develop more appropriate treatment plans [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement

    24. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to have a better understanding of underlying disease process and the role of specialist referral [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement

    25. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to more independently manage my PASC patients without referral to a specialist [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement

    26. Changes to practice by participating in randomized arm (teleECHO or monthly webinar) to apply specialist recommendations to patient care. [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement and free text

    27. Unable to apply learnings from randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey with use of Likert scale agreement and free text

    28. Other changes to practice by participating in randomized arm (teleECHO or monthly webinar) [During 30 months of follow-up]

      Clinician quarterly follow-up survey with free text

    29. Knowledge gained about topic presented during teleECHO before and after [During 33 months after each weekly ECHO session]

      Clinician intervention teleECHO survey

    30. Knowledge gained about topic presented during teleECHO before and after [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale knowledge

    31. Satisfaction with stated objectives being met [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale quality

    32. Satisfaction with session delivering balanced and objective, evidence-based content [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale quality

    33. Satisfaction with pace of session [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale quality

    34. Satisfaction with opportunities to ask questions [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale quality

    35. Satisfaction with organization of the presenters' presentations [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale quality

    36. Satisfaction with presenters' ability to clearly communicate [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale quality

    37. Desired content for future sessions [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey, free text

    38. Satisfaction with source evidence presented [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey Yes/No

    39. Satisfaction with commercial bias present [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey Yes/No and free text

    40. Recommendations for program improvement [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey free text

    41. Relevance of session to clinicians current work [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale relevance

    42. Intent to change practice based on learnings from session [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey Yes/No and free text

    43. Best part of session [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey free text

    44. Worst part of session [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey free text

    45. Recommend this session to a colleague [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey with use of Likert scale likelihood

    46. Changes to practice planned [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey free text

    47. If no changes to practice are planned, barriers [Through study completion, an average of 33 months]

      Clinician intervention teleECHO survey free text

    48. Participating clinician retention [Semi-annually during 33 months of follow-up]

      Mean number of months clinicians participate in the trial (intervention and control groups)

    49. Participating clinic settings [Semi-annually during 33 months of follow-up]

      Number of clinic settings in which providers see patients (intervention and control groups)

    50. Participation in intervention [Weekly during 33 months of follow-up]

      Number of weekly sessions each RCT (intervention) provider attends, and mean number

    51. Exposure of weekly teleECHO topics [Weekly during 33 months of follow-up]

      Number of topics covered in Weekly ECHO sessions RCT (intervention) provider attends

    52. Monthly webinar attendance [Monthly during 33 months of follow-up]

      Number of monthly webinars RCT providers attends

    53. Quarterly short course attendance [Quarterly during 33 months of follow-up]

      Number of quarterly short courses RCT providers attends

    54. Exposure of monthly webinar topics [Monthly during 33 months of follow-up]

      Number of topics covered in monthly webinars provider attends

    55. Exposure of quarterly short course topics [Quarterly during 33 months of follow-up]

      Number of topics covered in quarterly short courses provider attends

    56. Participation in case consultation [Quarterly during 33 months of follow-up]

      Number of patient cases presented by RCT (intervention) provider

    57. Participation in post-session survey [Weekly during 33 months of follow-up]

      Proportion of participants that complete each session poll (disaggregated by monthly webinar, weekly session, RCT vs. non-RCT provider)

    58. Volume of total patient case load [Monthly during 33 months of follow-up]

      Number of patients seen by RCT provider, and mean number (intervention and control)

    59. Volume of PASC patient case load [Monthly during 33 months of follow-up]

      Number of PASC patients seen by RCT provider, and mean number (intervention and control)

    60. Volume of patient referrals to specialists [Monthly during 33 months of follow-up]

      Number of referrals to specialists by RCT provider, and mean number (intervention and control)

    61. Application of specialist recommendations [Quarterly during 33 months of follow-up]

      Number of specialist recommendations applied by RCT (intervention) providers from weekly ECHO sessions

    62. Average consultation duration [Monthly during 33 months of follow-up]

      Mean duration of consultation for PASC patients by RCT providers, intervention and control

    63. Volume of specialists seen by patients [Monthly during 33 months of follow-up]

      Number of specialists seen by patient

    64. Specialty types patient was exposed to [Monthly during 33 months of follow-up]

      Number of specialty types the patient was exposed to

    65. Clinician session drop-off [Weekly during 33 months of follow-up]

      How long an (intervention) provider attended an ECHO session

    66. Quarterly attendance [Quarterly during 33 months of follow-up]

      Number of individuals who attended and watched short course

    67. Clinician satisfaction with series [End of study]

      Interview with Likert satisfaction

    68. Clinician overall best part of series [Up to 8 weeks after end of study]

      Interview

    69. Clinician overall worst part of series [Up to 8 weeks after end of study]

      Interview

    70. Clinician challenges in participating [Up to 8 weeks after end of study]

      Interview

    71. Perceived change in the relationship between clinicians and specialists in panel as a result of this series? [Up to 8 weeks after end of study]

      Interview, Yes/No with free response

    72. Clinician barriers to sustained participation in series [Up to 8 weeks after end of study]

      Interview

    73. Did clinician experience an improvement in the number of PASC patients they could manage at any given time as a result of the series? [Up to 8 weeks after end of study]

      Interview, Yes/No with free response

    74. Did clinicians experience an increase in PASC patients in their panel composition over time as a result of participation in the series? [Up to 8 weeks after end of study]

      Interview, Yes/No with free response

    75. Did clinic directors observe an increase in PASC patients in the clinicians panel composition over time as a result of their participation in the series? [Up to 8 weeks after end of study]

      Interview, Yes/No with free response

    76. Did clinicians experience an improvement in the quality of care for patients as a result of participating in the series? [Up to 8 weeks after end of study]

      Interview, Yes/No with free response

    77. Did clinic directors observe an improvement in the quality of care for patients as a result of a clinician participating in the series? [Up to 8 weeks after end of study]

      Interview, Yes/No with free response

    78. Did clinicians participating influence other providers in their clinic? [Up to 8 weeks after end of study]

      Interview, Yes/No with free response

    79. Did clinic directors observe clinicians who participated in the series influence other providers within the clinic? [Up to 8 weeks after end of study]

      Interview, Yes/No with free response

    80. Clinician benefits gained from participating in the series [Up to 8 weeks after end of study]

      Interview, free response

    81. Clinician recommendations for improving the scalability or sustainability of this model [Up to 8 weeks after end of study]

      Interview, free response

    82. Clinic directors recommendations for improving the scalability or sustainability of this model [Up to 8 weeks after end of study]

      Interview, free response

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with PASC, ME/CFS, and/or OPIFI, and 4) being willing and able to actively participate in LC&FIRP.
    Exclusion Criteria:
    • There are no exclusion criteria.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Family Health Centers of San Diego San Diego California United States 92102

    Sponsors and Collaborators

    • Family Health Centers of San Diego

    Investigators

    • Principal Investigator: Christian Ramers, MD, Family Health Centers of San Diego
    • Principal Investigator: Job Godino, PhD, Family Health Centers of San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Family Health Centers of San Diego
    ClinicalTrials.gov Identifier:
    NCT05167227
    Other Study ID Numbers:
    • HS-2021-0241
    First Posted:
    Dec 22, 2021
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Family Health Centers of San Diego
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 22, 2021